Comparison of two drugs in the treatment of a low risk treatable malignancy
- Conditions
- Health Condition 1: null- Low risk Gestational Trophoblastic Disease
- Registration Number
- CTRI/2012/11/003120
- Lead Sponsor
- Christian Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 150
Patients with abnormal hCG regression following any type of pregnancy (molar, term, abortion,ectopic) ie
(1)hCG plateau for 4 consecutive values over 3 weeks
(2)hCG rise of >10% for 3 values over 2 weeks
(3)hCG persistence 6 months after molar pregnancy evacuation
For staging and pretreatment evaluation, all patients will undergo complete physical and pelvic examination, complete blood cell count, urinalysis, liver and renal function tests, and chest x-ray. Ultrasonography and/or computed tomographic scanning will be performed when clinically indicated. Diagnosis, staging, and risk scoring will be as per International Federation of Gynecology and Obstetrics (FIGO) 2000 criteria for diagnosis and staging for GTN.
Low risk gestational trophoblastic disease FIGO score <6
•Choriocarcinoma
•Any patient with renal, hepatic,haematological disease
•Pregnancy
•Prognostic score > 6
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary remission rate or Complete response (Proportion)Timepoint: 5years
- Secondary Outcome Measures
Name Time Method Time to cure <br/ ><br>Number of cycles required for complete response <br/ ><br>Toxicity & Side effects <br/ ><br>Cost of treatment <br/ ><br> <br/ ><br>Timepoint: 5 years